Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

What Was Tested

This registered phase 3 trial tested Icatibant.

It had two arms (groups): Icatibant (experimental) and Placebo (placebo comparator).

Placebo will be administered as a single subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

Angiotensin-converting enzyme inhibitors (ACE-Is) are the class of medications prescribed most frequently for the treatment of hypertension.

They are also used post myocardial infarction as well as in patients with heart failure, diabetes mellitus, and chronic kidney disease.

Study HGT-FIR-096 is a multicenter, Phase III, randomized, double-blind, two-armed, placebo-controlled trial.

Who Took Part

The registry lists 118 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, 18 years of age or older. Patient is currently being treated with an ACE inhibitor. Angioedema must be considered at least moderate in severity for at least one of the four angioedema-associated airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling). Patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: patients with a family history of recurrent angioedema; patients who have had a previous episode(s) of angioedema while not on ace inhibitor therapy; patients with acute urticaria (itchy, erythematous wheals).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Icatibant study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Icatibant, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2013-12-02 with completion listed for 2015-08-22.

It ran at 55 sites in United States (43), United Kingdom (5), Israel (4) and Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Meeting Discharge Criteria (TMDC) (time frame: Day 0 up to Day 5). Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From start of study drug administration (Day 0) up to follow-up (Day 5)). Number of Participants With Treatment Emergent Injection Site Reaction (time frame: Day 0 to Day 5).

It also tracked 5 secondary outcomes, for example Time to Onset of Symptom Relief (TOSR), Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema, Number of Participants Admitted to Hospital or Intensive Care Unit (ICU), Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration and Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Icatibant in 118 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Icatibant compound page, all human trials.